Medical Devices
This area of our activities is quite new and already proven to be successful. Clinical evaluation/investigation of medical devices is an essential process in their way to the commercial market. While the clinical trials for pharmaceuticals and medical devices have many similarities, there are still differences when it comes to design and conducting.
Medical devices are a large group of dissimilar products that have a very wide variation in the degree of contact with the body and its influence on it. Therefore, evaluating their clinical performance and safety may require very different types of clinical trials – be that small pilot studies involving 10-30 patients, larger pivotal studies in 150-300 subjects, or post-registration studies in a population. Mainly, we focus on medical devices that have some resemblance to drugs or act as active substance delivery systems.
In the area of Medical Devices we offer full-service of clinical evaluation/clinical investigation as well as individual services, e.g., selection of clinical centers and investigators, obtaining the regulatory approval, study set-up, monitoring, site management, etc.
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Strengths of Targeted Market
■ ■ ■ CLS Site Networks are built mainly in the post-Soviet countries (ex-USSR), with a supportive regulatory environment. The doctor–patient relationship is a central part of healthcare practice in this region which is very favourable for clinical trials. Another benefit is a large number of the treatment naïve patients. Both the company and sites are staffed with experienced experts having medical degrees (MD) including Site Coordinators. Experienced, flexible, and manageable Principal Investigators provide full support of the company and its employees. ■ ■ ■